Institutional Review Board

The AUM IRB (Institutional Review Board) functions to protect the rights and welfare of human research participants. As such, the IRB reviews all research activities, regardless of funding, which involves human subjects for compliance with applicable federal, state, local, and institutional regulations, guidelines, and ethical research principles. All funded research involving human subjects must be reviewed and approved under IRB procedures, prior to receiving funding. The IRB has the authority to approve, require modifications (to secure approval), and disapprove research proposals and to suspend or terminate research that is not conducted in accordance with the IRB's requirements or that has been associated with any possible harm to subjects. Standards for review of research protocols are based on the Belmont Report, Nuremburg Code, and World Medical Association upon which federal regulations have been written to support.

AUM Institutional Review Board

Federal regulations require that all proposed human subjects studies undergo review and approval by the Institutional Review Board (IRB). The IRB is responsible for reviewing all human subjects research and ensuring compliance with federal regulations. The primary role of the IRB is to protect the safety and welfare of human subjects. AUM’s IRB is responsible for oversight of all research activities involving human subjects on the AUM campus, utilizing AUM resources, involving AUM students, staff, or faculty. The review ensures compliance with all applicable federal and state laws/ regulations, ethical considerations, and includes initial, continuation, modifications, unanticipated problems and alleged noncompliance.

Federalwide Assurance

AUM has obtained FWA (FederalWide Assurance) from the U.S. Dept. of Health & Humans Services (HHS) and Office of Human Research Protections (OHRP). As an FWA institution, AUM has assured that we will abide by the Section 101(h) of the Common Rule (45 CFR part 46 subpart A) by supporting a full and functioning IRB (with sufficient staff, space, training and resources) to protect humans subjects in research activities. Policies have been established in compliance with federal regulations that guide the use of human subjects in all types and phases of research projects. The registration numbers assigned to AUM for FWA and IRB are:

FWA#: 00012889. (Expiration date: May 1, 2020)

AUM IORG #: 0005227

AUM IRB #: IRB00006286

Federalwide Assurance registration is required of any institution applying for research funding (using human subjects) with a federal agency.

Training

AUM faculty/staff/students: One method to assure compliance with regulations and assure protection of human subjects is to provide training for researchers. All researchers, staff, students, and others who interact with human subjects (all research team members) must complete a required educational program on the protection of human subjects before the IRB can review a proposal. AUM is providing this training through CITI (Collaborative Institutional Training Initiative) http://www.citiprogram.org .This certification process must be completed and documented with the IRB office (and renewed every five years). Beginning January 1, 2010, a new protocol will not be accepted by the IRB until all members of the research team have completed the CITI training and the training documented in AUM’s IRB office.

Non AUM affiliated personnel: That engage in human subjects research at AUM through a collaboration must also obtain training in human subjects protections. CITI serves almost 900 institutions worldwide so it is very possible that the researcher can obtain CITI training at their institution of primary affiliation. If there is no CITI training available, the AUM IRB will accept NIH (National Institute of Health) Protecting Human Research Participants training available. There is no cost for this course. It is the responsibility of the researcher to print the training completion certificate and provide to the AUM IRB office.

All human subjects research projects must be submitted for review on the the IRB Protocol Form